GUEST COLUMNISTS

• Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers

  Effective mAb and ADC manufacturing control strategies evolve through the phases. These four principles should guide your strategy design as goals shift.

• High Specific Productivity For Leaner Sustainable Bioprocessing

  Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.

• New ISPE Framework Targets Uncertainty In Pharma's AI Deployment

  International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

• Facility Considerations When Retrofitting Legacy Sites For ADCs

  Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.

• In Vivo's Biggest Threat — Comparison To Old Models

  In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.

• Managing Supply Chain Risk In Scale-Up And Multisite Trials

  Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.

• The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing

  The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

• Why Use Total Organic Carbon Analysis For Cleaning Validation?

  Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.